Safety and efficacy of bimekizumab for PsA up to 52 weeks: BE VITAL open-label extension

BE COMPLETE was a 16-week phase III placebo-controlled trial. Additional information about BE COMPLETE has previously been published on the Psoriasis and Psoriatic Arthritis Hub. 

Patients who completed the BE COMPLETE trial entered the BE VITAL OLE, in which patients received bimekizumab 160 mg every 4 weeks for up to 140 weeks.  

Included patients who had active PsA with a baseline tender joint count ≥3, swollen joint count ≥3, and ≥1 active psoriatic lesion and/or a history of psoriasis.  

Intolerance or an inadequate response to one or two TNFi for the treatment of psoriatic disease was required. 

A total of 377 patients (256 randomized to bimekizumab and 12 randomized to placebo) were included in the BE VITAL OLE. 

Efficacy, as measured by American College of Rheumatology scores and Psoriasis Area and Severity Index, was improved compared with placebo at Week 16, and sustained to Week 52 in patients treated with bimekizumab (Figure 1). 

In patients who switched to bimekizumab from placebo, rapid improvements in American College of Rheumatology scores occurred after 12 weeks of treatment and were observed up to Week 52.  

To Week 52, the most common treatment-emergent adverse events in patients treated with bimekizumab were COVID-19 infection (7.2%), oral candidiasis (6.2%), nasopharyngitis (5.9%), and urinary tract infection (5.9%). 

All Candida infections in bimekizumab-treated patients were of mild or moderate severity. 

There was one sudden death and one cerebral hemorrhage during BE VITAL, which were unrelated to the study treatment.